Loading…
Rocky Top Vapor, LLC was cited for manufacturing and distributing e-liquid tobacco products without obtaining required premarket authorization from the FDA. The company's e-liquids, offered for sale through their website, were deemed tobacco products under the Family Smoking Prevention and Tobacco Control Act and fell under FDA jurisdiction as of August 8, 2016, but lacked the legally mandated marketing authorization order necessary for new tobacco products. The violation centered on the company's failure to comply with section 910 of the Federal Food, Drug, and Cosmetic Act, which requires premarket approval before any new tobacco product can be legally marketed in the United States.